Senior Regulatory Affairs Specialist
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Job Description
Senior Regulatory Affairs Specialist supporting regulatory strategy and compliance across Natera's products and services, collaborating with internal teams and external stakeholders.
Responsibilities:
- Support preparation of pre-submissions to regulatory authorities providing guidance to teams on regulatory strategy and requirements;
- Support regulatory submissions for in vitro diagnostic devices including IDEs, EU/IVD Technical Documentation, classification requests, pre-submissions, and updates to registrations worldwide.
- Contribute to the setting of individual and departmental annual goals aligned with business objectives.
- Review and ensure regulatory compliance of advertising, promotion and labeling across a common product line.
- Support regulatory affairs efforts in new and existing technology project teams to implement regulatory strategy and meet regulatory requirements towards overall success of the project deliverables.
- Support regulatory deliverables on behalf of internal and external program teams.
- Build specialized knowledge of regulatory guidelines and requirements within one or more fields applicable to Natera; maintain excellent records of regulatory interactions and reports, contribute to the effectiveness of the RA team.
Requirements:
- 4-6 years biotech industry experience
- Associate's Degree / certificate, B.A., B.S., or equivalent. Work experience may be considered in lieu of education.
Benefits:
- Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
- Free testing for employees and their immediate families.
- Fertility care benefits.
- Pregnancy and baby bonding leave.
- 401k benefits.
- Commuter benefits.
- Generous employee referral program.
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